BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3

    K Number: K984277 · Decision Dec 9, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    96
    Applicant Total
    107
    Review Days
    9

    Basic Information

    Device Name
    CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3
    K Number
    K984277
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    MEDICAL ANALYSIS SYSTEMS, INC.
    Date Received
    November 30, 1998
    Decision Date
    December 9, 1998
    Product Code
    JJT
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JJT Enzyme Controls (Assayed And Unassayed)

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    Other Clearances by MEDICAL ANALYSIS SYSTEMS, INC.

    K Number Device Name
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    K040880 MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3
    K032826 MAS PAR TDM
    K032335 MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL
    K031890 MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL
    K031392 MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL
    K031441 URICHEMTRAK LIQUID ASSAYED URINE CONTROL
    K031364 MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3
    K030942 MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL
    Search all 107 clearances from MEDICAL ANALYSIS SYSTEMS, INC. →